partial AUCs for locally acting MR [Design Issues]

posted by jag009  – NJ, 2020-12-05 09:01 (1605 d 00:20 ago) – Posting: # 22116
Views: 3,865

Hi,

❝ I’m involved in the development of a MR generic drug that is locally acting in the GI tract. Despite the very helpful new EMA guideline (Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract, CPMP/EWP/239/95 Rev. 1, Corr.1*) I´m struggling with designing the BE studies to support submission in EU.


❝ Most problematic is the justification of the cut-off for the required partial AUCs.


Something like this in US for mesalamine ER?

https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022301.pdf

J

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,670 registered users;
105 visitors (0 registered, 105 guests [including 9 identified bots]).
Forum time: 10:22 CEST (Europe/Vienna)

There are two possible outcomes: if the result confirms the
hypothesis, then you’ve made a measurement. If the result is
contrary to the hypothesis, then you’ve made a discovery.    Enrico Fermi

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5